FDA extends indication for FluLaval Quadrivalent for infants six months and older

The US Food and Drug Administration’s Center for Biologics Evaluation and Research has approved  expanding the indication for FluLaval Quadrivalent (Influenza Vaccine) to include use in children six months and older.

Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons three years of age and older, noted UK pharma major GlaxoSmithKline (LSE: GSK), the products manufacturer. For whom FluLaval/Fluarix generated sales of £351 million ($442 million) for the first nine months of this year.

“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the US every flu season,” said Patrick Desbiens, senior vice president, US Vaccines, adding: “Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness. This expanded indication builds upon GSK’s commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the US market.”